Recall Z-0290-2017 ยท KWP Appliance, Fixation, Spinal Interlaminal
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confi
| Date | Oct 20, 2016 (initiated Sep 16, 2016) |
| Status | Terminated |
| Reason | RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury. |
| Root cause | Process control |
| Action | RTI issued e-mail cutsomer notices for their voluntary recall of lots 234829 and 234829 of the Streamline OCT Straight Rod, CoCr, 3.2mm (D) x 240mm (L) on 09/16/2016. RTI Surgical has produced replacement implants that have been verified as not containing any cracks. These implants will be sent to customers once they have identified how many replacements are needed. Please follow the below instructions. 1. Review inventory located in your facility and any other point of use locations that you may be responsible for. Immediately quarantine any implants listed in this recall notice. Please ref |
| Quantity | 66 |
| Distribution | US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), Apr 28, 2015 |